NCT03099421

Brief Summary

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

March 28, 2017

Last Update Submit

December 18, 2018

Conditions

Hyperplasia ProstaticLower Urinary Tract SymptomsProstatic DiseasesUrological Manifestations

Keywords

Benign prostatic obstructionbenign prostatic enlargementbenign prostatic hyperplasiaprostatic artery embolizationQuality of LifeIPSSDAN-PSSComplications

Outcome Measures

Primary Outcomes (1)

  • Ability to void spontaneously

    Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months

    6 months

Secondary Outcomes (7)

  • IPSS

    1, 6 months

  • QoL

    1, 6 months

  • IIEF

    1, 6 months

  • PV

    1, 6 months

  • PVR

    1, 6 months

  • +2 more secondary outcomes

Study Arms (1)

Prostatic Artery Embolization

EXPERIMENTAL

Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Procedure: Prostatic Artery Embolization

Interventions

Prostatic Artery EmbolizationPROCEDURE

The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.

Prostatic Artery Embolization

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or
  • Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment
  • Unsuitable for TURP or refuse surgery

You may not qualify if:

  • Bladder dysfunction(and known neurological conditions affecting bladder function)
  • Urethral strictures
  • Bladder neck contracture
  • Known sphincter anomalies
  • Big bladder diverticulum or stones
  • Kidney insufficiency (eGFR \< 45)
  • Coagulation disturbances
  • Severe atheromatous or tortuosity of arteries
  • Allergy to contrast medium
  • Unable to undergo MR imaging
  • Urological malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract SymptomsProstatic DiseasesUrological Manifestations

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Lönn, Professor

    Radiologisk Klinik, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

March 22, 2017

Primary Completion

December 14, 2018

Study Completion

December 14, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)